Department of Health and Human Services June 15, 2021 – Federal Register Recent Federal Regulation Documents

Advisory Committee on Immunization Practices (ACIP)
Document Number: 2021-12578
Type: Notice
Date: 2021-06-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. The meeting will be webcast live via the World Wide Web. Time will be available for public comment.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-12572
Type: Notice
Date: 2021-06-15
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: 2021-12571
Type: Notice
Date: 2021-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Lederle Laboratories et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications; Correction
Document Number: 2021-12557
Type: Notice
Date: 2021-06-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on May 12, 2021. The document announced the withdrawal of approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of June 11, 2021. The document indicated that FDA was withdrawing the approval of ANDA 060164, Nystatin Ointment, held by Lederle Laboratories. However, the document published with an incorrect application number for this product. This document corrects that error.
National Cancer Institute; Notice of Meeting
Document Number: 2021-12511
Type: Notice
Date: 2021-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-12510
Type: Notice
Date: 2021-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport
Document Number: 2021-12505
Type: Notice
Date: 2021-06-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for the generic device type, powered patient transport, all other powered patient transport. These devices are motorized devices used to mitigate mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs. This device type does not include motorized three-wheeled vehicles or wheelchairs, and is distinct from the device type, powered patient transport, powered patient stairway chair lifts, which is classified separately within the same regulation. FDA is publishing this notice to obtain comments in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Evaluation of Study Data Exchange Standards for Submission of Study Data to the Center for Veterinary Medicine; Request for Comments
Document Number: 2021-12503
Type: Notice
Date: 2021-06-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is soliciting comments on the use of study data exchange standards from persons involved in study conduct, data collection, data management, and submission of animal study data intended to support the approval of new animal drug applications, abbreviated new animal drug applications, or applications for conditional approval.
Proposed Information Collection Activity; Tribal Maternal, Infant, and Early Childhood Home Visiting Program: Guidance for Submitting an Annual Report to the Secretary (OMB #0970-0409)
Document Number: 2021-12464
Type: Notice
Date: 2021-06-15
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Child Care (OCC) is requesting a 3-year extension of the Tribal Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program: Guidance for Submitting an Annual Report to the Secretary (OMB #0970- 0409; expiration 9/30/2021). There are minor updates to the annual guidance which reflects a change in timing for the due date of the final report.
Medicare Program; Virtual Public Meetings in July 2021 for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set
Document Number: 2021-12453
Type: Notice
Date: 2021-06-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the dates and times of virtual Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in July 2021 to discuss our preliminary coding recommendations for new revisions to the HCPCS Level II code set.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2021-12451
Type: Notice
Date: 2021-06-15
Agency: Department of Health and Human Services, National Institutes of Health